EMA publishes final version of Biosimilar guideline

November 9, 2014

On 29 October 2014, EMA presented the final version of their guideline on biosimilars. This document replaces the previous guidance document of 2005, provides several clarifications and introduces one important change intended to ease global development of biosimilars.

Asphalion attended CPhI (7 – 9/10 in Paris, FR)

October 8, 2014

CPHi is one of the most important events in the Pharmaceutical Industry, mainly focused on pharma market news and trends on a global scale.

Asphalion attended BIOSPAIN 2014 (24 – 26/09, Santiago de Compostela)

September 18, 2014

Our team also attended Xacobio, a three-day walk before Biospain on the Camino de Santiago.

AEMPS: improvements in fee payment system

August 27, 2014

As from 1 October the AEMPS, will have a new bank payments gateway available so as to increase payment security and facilitate procedures.

European Comission: Notice to applicants, update of variations and renewal application forms (human and veterinary)

June 17, 2014

The Notice to Applicants, has been updated with an application form for the submission of variations and renewal.

Asphalion attended AEFI 2014 (04 – 05/06 – Madrid, Spain)

June 5, 2014

During the Symposium we taught 2 workshops.

Asphalion attended ECRD 2014 (08 – 10/05, Berlin)

May 9, 2014

Lidia Canovas, and our US Agent, Bruce Thompson were at the European Conference on Rare Diseases and Orphan Products.

AsphaNews 5: May 2014

April 29, 2014

The latest developments in the dynamic world of Drug Development, Regulatory Affairs and PhV.

Complimentary Webinar: Get Ready for the 2014 xEVMPD Requirements (3rd April 2014)

April 1, 2014

Use EXTEDO’s free-of charge solution MPDviewer

Asphalion attended DIA’s 26th Annual EuroMeeting in Vienna (25-27 March 2014)

March 18, 2014

Over the years, this conference has become a real centre of attention for regulatory professionals and related life science experts.

Complimentary Webinar: Get Ready for the 2014 xEVMPD Requirements

February 20, 2014

Use Extedo’s free-of charge solution MPDviewer

FDA GDUFA Performance Report

February 10, 2014

FDA published the Generic Drug User Fee Amendments of 2012 (GDUFA) Performance Report

New requirements in Spain for presentation of SmPC and PIL

January 22, 2014

This new procedure is now also mandatory for any kind of variation that modifies these documents.

AsphaNews 4: January 2014

January 16, 2014

The latest developments in the dynamic world of Drug Development, Regulatory Affairs and PhV.

Asphalion is a proud member of the iHivarna consortium

December 18, 2013

The four-year 6M Euro project, funded by the European Commission, aims to successfully immunize antiretroviral-treated HIV-infected patients.

Asphalion at BIO-Europe 2013

November 4, 2013

Meet several consultants of ASPHALION at the 19th annual BIO-Europe conference in Vienna.

Highlights of the New Real Decreto RD 577/2013 on Pharmacovigilance

November 4, 2013

The New Real Decreto RD 577/2013 on Pharmacovigilance was published on 27th July 2013.

AsphaNews 3: October 2013

November 4, 2013

We are excited to present the new issue of our newsletter: ASPHAnews